UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of muscular function therapy on tongue thrust- Investigation by multi modality analysis
Title of the study (Brief title)	Effect of muscular function therapy on tongue thrust
Region	Japan

Condition
Condition	tongue thrust
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to measure the temporal movement of the tongue and oropharyngeal part during swallowing by using MRI movie that has never been adapted during swallowing in the group with tongue protruding habits, It is to investigate the mutual relationship in the temporal change of the tongue pressure distribution, the change of the masticatory muscle, the activity of the muscularis muscle around the oral cavity, the change of the peripheral blood flow rate of the masticatory muscle, and to elucidate the influence on the jaw and dentition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MRI movie
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Behavior,custom
Interventions/Control_1	myofunctional therapy
Interventions/Control_2	tongue thrust
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy person
Key exclusion criteria	birth defect syndrome
Target sample size	60

Research contact person
Name of lead principal investigator	MIYAMOTO JUN
Organization	Tokyo medical and dental university
Division name	Department of Maxillofacial Orthognathics
Address	1-5-45 Yushima, Bunkyu-ku, Tokyo
TEL	0338136111
Email	j-miyamoto.mort@tmd.ac.jp

Public contact
Name of contact person	NAKAMURA RURIKO
Organization	Tokyo medical and dental university
Division name	Department of Maxillofacial Orthognathics
Address	1-5-45 Yushima, Bunkyu-ku, Tokyo
TEL	0358035536
Homepage URL
Email	ruriiiiiko@gmail.com

Sponsor
Institute	Tokyo medical and dental university Department of Maxillofacial Orthognathics
Institute
Department

Funding Source
Organization	Tokyo medical and dental university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 02 Month 25 Day
Last modified on	2019 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041010